Ropes & Gray provides counsel, representation, and strategic advice to companies subject to Food and Drug and related law.  Command of FDA regulatory matters and associated issues in patent and antitrust law is critical when seeking product approvals, developing an effective lifecycle management strategy, and in assuring that products are marketed in compliance with federal and state requirements. Our lawyers have served in Congress and in the administrative agencies of the federal government; this experience is extraordinarily valuable when designing and carrying out a plan to address our clients’ concerns.

We advise established and development-stage pharmaceutical and medical device manufacturers and distributors on the requirements and strategies to pursue marketing authorizations including NDAs, BLAs, PMAs, and 510(k)s. With more than 25 years of experience on Hatch-Waxman Act and Orphan Drug issues, we have an in depth understanding of the competitive issues that affect the industry. We are also recognized leaders in the field of pharmaceutical promotion and compliance and have represented major pharmaceutical and biotech companies in areas ranging from biologics regulation to Rx and OTC switches.

Our FDA experience, combined with our extensive knowledge in related areas such as research funding, health care regulatory matters, clinical trials, and legislation is rare in law firms.  It allows us to thoroughly understand complex issues and to offer our clients an opportunity for coordinated action in conjunction with the firm’s patent, government enforcement, and transactional lawyers in several areas, including:

• Product Approvals
• Labeling, Advertising, and Other Promotional Activity
• FDA Enforcement Actions
• Federal Policy
• Due Diligence Reviews
• Fraud & Abuse
• Reimbursements

---

©2008 Ropes & Gray LLP. All rights reserved.